Oral Iron Supplementation in Pulmonary Hypertension

Overview

The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2014

Detailed Description

Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.

Interventions

  • Dietary Supplement: iron supplement
    • 325 mg tablets by mouth once a day for 1 week, then twice a day for 1 week, then three times daily for the remainder of the 3-month study period.

Arms, Groups and Cohorts

  • Experimental: iron supplement
    • open-label iron supplement intervention group

Clinical Trial Outcome Measures

Primary Measures

  • Change in Zinc protoporphyrin from baseline
    • Time Frame: 3 months
  • Change in serum ferritin from baseline
    • Time Frame: 3 months

Secondary Measures

  • Change in serum erythropoietin from baseline
    • Time Frame: 3 months
  • Change in transferrin saturation from baseline
    • Time Frame: 3 months
  • Change in 34+/133+ cells from baseline
    • Time Frame: 3 months
  • Change in pulmonary arterial pressure from baseline
    • Time Frame: 3 months
    • estimated using echocardiogram
  • Change in six minute walk distance from baseline
    • Time Frame: 3 months
  • NYHA/WHO classification
    • Time Frame: 3 months
  • Side effects of iron supplementation
    • Time Frame: 3 months
  • Deaths and hospitalizations greater than 24 hours
    • Time Frame: 3 months

Participating in This Clinical Trial

Inclusion Criteria

  • age 21 and older – diagnosis of idiopathic pulmonary arterial hypertension – iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l) Exclusion Criteria:

  • active infection, malignancy, or bleeding – hemochromatosis – chronic inflammatory or autoimmune disease – currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants – allergy to iron

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Cleveland Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Samar Farha, MD, Staff Pulmonologist – The Cleveland Clinic
  • Overall Official(s)
    • Samar Farha, MD, Principal Investigator, The Cleveland Clinic

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